NCT04780893

Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD

A Randomized, Double Blind Sham Controlled, Pilot Study to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS) for Sleep Management in People With Post- Traumatic Stress Disorder (PTSD).

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This double blind randomized controlled study will enroll 20 subjects and will be conducted remotely. The study will be randomized for an 8-week period with a 1:1 active to sham device allocation. Primary endpoint analysis will be performed at 4 weeks.

Conditions

• PTSD
• Sleep Disturbance
• Insomnia

Interventions

Type	Name	Description
DEVICE	Modius Sleep	The device utilizes a technology called vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-03-04
• Last updated: 2024-01-16